Provide technical oversight and maintain quality systems that are effective and comply with federal, state, local, and other applicable regulations and standards, as well as in accordance with internal Bausch & Lomb policies and procedures for the St. Louis site Disposable Value Stream.
Provide technical oversight for cleanroom and terminal sterilization (Gamma & ETO) processes.
Report on the performance of the quality system to the St. Louis site management.
Support product changes and new product development.
Monitor the effectiveness of quality improvements and validation activities as part of the CAPA process.
Manage processing of materials through finish product release.
Specific focus on Environmental Monitoring, Sterilization, Clean Room Procedures, Root Cause Analysis and Validation.
Drive quality data analysis (fishbone diagrams, pareto analysis, etc.) and coordinate activities to make product and process improvements. Review sources of Quality Data including process yields, complaint data and EM reports to identify any necessary CAPA activities. Serve as overall CAPA coordinator for your area.
Quality Systems :
Develop and maintain quality assurance procedures and work instructions regarding inspection and data gathering/analysis.
Monitor product quality through inspection, testing, and auditing. Monitor environmental control, process validation, and sterilization methods, where applicable.
Work with operating entities to establish and maintain procedures for inspection, process control, data analysis and product conformance. Issue reports on KPIs to appropriate management.
Assist in Product Complaint evaluations and investigations.
Bachelor of Science Degree in Engineering or Related Science Field (or equivalent experience)
Process validation; statistical process control, root cause investigation, problem solving
Three+ years of experience working in the Quality Assurance field. Experience working with FDA and ISO 13485 Quality System Regulations.
Experience working in a Cleanroom environment. Working knowledge of Sterilization methodologies (Gamma & ETO) and basic microbiology
FDA GMP training; Sterilization techniques (Gamma & ETO); Cleanroom operations and monitoring.
Basic statistical including trends, pareto and other basic charting techniques.